THE O R COMPANY CTS35-TV ColpotomizOR Tube System Instruction Manual

: June 9, 2024
: THE O R COMPANY

Table of Contents

INDICATIONS FOR USE I CLINICAL BENEFITS
CONTRAINDICATIONS
CAUTIONS / WARNINGS
INSTRUCTIONS FOR USE
Documents / Resources

CTS35-TV
CTS45-TV
INSTRUCTIONS FOR USE: ColpotomizOR Tube System™
Trans-Vaginal Tube and Uterine ManipulatOR
Instruction Manual

INDICATIONS FOR USE I CLINICAL BENEFITS

The ColpotomizOR Tube SystemTM is indicated for manipulation of the uterus in laparoscopic gynecological procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH). It is intended for insertion under direct visualization for secondary port location. The ColpotomizOR Tube System TM can be inserted trans-vaginally to establish a path of entry for minimally invasive instruments, and can be used as a template for dissection for gynecologic surgical procedures. The instrument is a conduit for the extraction of specimens. The device facilitates a more atraumatic manipulation and mobilisation of uterus/cervix, in addition to providing enhanced definition and visualisation of vital structures and anatomical landmarks, enabling safe dissection, division, coagulation and suturing. Patients benefit from less pain and discomfort, lower operative and post-operative risks, and a faster post-operative recovery.

CONTRAINDICATIONS

Device should not be used in:

Patients with known or suspected uterine or tubal infection,
Patients with known or suspected pregnancy, or
Patients with a short (<4cm) uterine length, or
Patients with early stage cervical malignancy undergoing a laparoscopic approach.

This device is not intended for use as a Laser Backstop.

CAUTIONS / WARNINGS

All users must read and be familiar with all the instructions, warnings, contraindications and precautions in this package insert before using the device.

This device should be used only by surgeons trained in intrauterine surgery, laparoscopic surgery, diagnostic procedures, gynecological pelvic anatomy, and placement of intrauterine retracting instruments.
Caution should be exercised when using this device in patients with cervical or uterine pathology and in patients with gynecological malignancy.
Caution should be exercised when using this device in patients who have undergone preoperative and/or intraoperative radiation therapy, have traumatized tissues, or have undergone previous ablation procedures.
Before inserting the ManipulatORTM or other accessory instruments into the valves, the valve site and instrument should be lubricated with sterile lubricant.
After assembly of the ManipulatOR into the ColpotomizOR Tube and prior to use, test the intrauterine balloon for proper inflation and function by inflating and deflating the intrauterine balloon with up to 10cc air.
Check for the need to dilate cervix before insertion of the ManipulatORTM. The cervical os should be at least 6mm (0.24in) in diameter to facilitate safe insertion and to reduce the risk of uterine perforation, injury to the cervix and/or intrauterine balloon rupture.
DO NOT insert or remove the ManipulatORN with intrauterine balloon inflated.
DO NOT use excessive force when using this device, to avoid traumatizing the vaginal canal and/or component detachment.
To avoid potential injury to the uterine wall or inadvertent expulsion of the device from the uterus during the procedure, DO NOT under-inflate the intrauterine balloon. Inflation of air to slight resistance is met or 10cc, whichever comes first, is recommended. DO NOT exceed 10cc of air.
As with all intrauterine devices, improper use carries a risk of uterine perforation and subsequent bleeding. If the surgeon has used the ManipulatORTM and the uterus has not been removed, the surgeon should examine the patient carefully for any indications of uterine perforation and subsequent bleeding and take appropriate clinical steps.
DO NOT use this device to manipulate when the intrauterine balloon is deflated.
DO NOT use any liquids to inflate the intrauterine balloon. Use of fluid could potentially over distend and rupture the balloon.
The ManipulatORTM must be inserted along the direction of the uterine cavity, (anteriorly in an anteverted uterus, posteriorly in a retroverted uterus) to reduce the potential of uterine perforation. Pelvic examination should be performed to determine the direction of the uterus. Sound the uterine cavity to assess the uterine depth. Extra caution should be exercised in the case of a very small uterus. DO NOT use the ManipulatORTM if the uterus sounds to less than 4cm (1.6in).
The ManipulatORTM is not recommended for use in a large, post-partum uterus as movement of the device may result in uterine wall lacerations and subsequent bleeding.
When the device is in use, ensure the grommet stopper (5, Figure 1) is not moved unless required.
Lubricate the tip of the ManipulatORTM and bevelled end of the Tube before insertion.
Vaginal delivery of a large uterus may result in patient injury. Methods to reduce the size of the uterus prior to removal through the vaginal canal should be considered.
Caution must be used when using energy devices with this device. Any prolonged direct contact may damage the device.
In laparoscopic supracervical hysterectomy, contact between the ManipulatORTM and dissecting instruments must be avoided during uterine dissection and excision to reduce the risk of patient injury. Damage to the device and/or intrauterine balloon rupture may also occur.
If bending of the ManipulatORTM is deemed necessary for use with robotic instruments, all device systems must first be tested prior to use to ensure functionality.
The ManipulatORTM is NOT to be used for fluid injection or dye studies.
Device designed for short term use but not for more than 24 hours.
DO NOT reuse this device. The device is intended for single use only. The design of this device may not perform as intended by the manufacturer if it is reused. The manufacturer cannot guarantee the performance, safety and reliability of a reprocessed device.
DO NOT use the ColpotomizOR Tube SystemTM as a uterine sound.
Device is sterile if the package is dry, unopened and undamaged. DO NOT use if the pouch is damaged or the packaged seal is broken.

INSTRUCTIONS FOR USE

After vaginal examination select the appropriate ColpotomizOR Tube System TM size.
Remove the ColpotomizOR Tube SystemTM from the sterile packaging and inspect for any damage caused by shipping. Discard if any damage is noted.
Lubricate the tip and intrauterine balloon (1, Figure 1) of the ManipulatORTM with a sterile surgical lubricant and insert the ManipulatORTM into the top, 10mm/12mm instrument valve of the ColpotomizOR Tube TM . For easy insertion ensure that the instrument valves are also lubricated.
Test the integrity of the intrauterine balloon of the ManipulatORTM by drawing 10cc of air into a luer slip syringe and insert syringe into the valve (7, Figure 1). Inject air to confirm balloon remains inflated. DO NOT USE if intrauterine balloon does not remain inflated. Discard and use another ManipulatORTM unit. After the successful balloon test, deflate the balloon by removing all air with the syringe and remove syringe.
The patient should be placed in lithotomy dorsal position.
With the cervix under direct visualization, the surgeon should use standard surgical technique to grasp the anterior cervical lip with an appropriate clamp or similar toothed instrument.
If necessary, sound the uterus to determine approximate depth. The graduations are provided as guide for comparison to a graduated uterine sound.
If required, dilate the cervix to accommodate the 6mm (0.24in) diameter of the ManipulatORTM shaft.
Lubricate the tip and intrauterine balloon (1, Figure 1) of the ManipulatORTM and the bevelled end (2, Figure 1) of the ColpotomizOR Tube TM with a sterile surgical lubricant.
9. Lubricate the tip and intrauterine balloon (1, Figure 1) of the ManipulatORTM and the bevelled end (2, Figure 1) of the ColpotomizOR Tube TM with a sterile surgical lubricant.
Carefully insert the ColpotomizOR Tube System TM into the vagina. Advance the ManipulatORTM through the ColpotomizOR Tube TM to maximize visibility of the cervical os.
If required, a flexible suction tube with internal diameter of 4mm may be connected to the suction port. When a tube is not connected, ensure the suction port is closed using the suction port cap.
Carefully insert the proximal tip of the ManipulatORTM through the cervical os until the balloon is in the desired position within the uterine cavity. If the uterus is retroverted, rotate the ManipulatORTM 180° prior to inserting the intrauterine balloon. Once the ManipulatORTM is in place inside the uterus, advance the Tube to the cervix and adjust the stopper (5, Figure 1) to sit flush with the three-port cap. The ColpotomizOR Tube TM should then be secured to the patient drapes using the silicone tie (even when held by an assistant).
Using the handle (6, Figure 1), stabilize the external end of the ManipulatORTM to prevent inadvertent displacement or forward movement of the ManipulatORTM until positioned.
Reattach the syringe to the inflation valve and inflate the intrauterine balloon with air until you feel resistance or 10cc of air has been injected, whichever comes first. DO NOT exceed 10cc of air. Carefully remove the syringe to close valve and prevent inadvertent deflation of the balloon due to backward pressure.
0nce inflated, rotate the ManipulatORTM 180° to antevert the uterus.
To remove the ManipulatORTM, fully deflate the intrauterine balloon using prescribed method in Step 4. This can be performed to release the uterine specimen in-uteri or ex-uteri.
After delivering the specimen via the ColpotomizOR TubeTM, the ColpotomizOR Tube TM should be washed in sterile water before being re-lubricated and re-inserted with the closing suture.
Carefully remove the ManipulatORTM and the ColpotomizORTM Tube from the vagina. DO NOT use excessive force to avoid traumatizing the vaginal canal.
Before disposing of the ColpotomizOR Tube SystemTM visually inspect the device to check it is intact and all components have been retrieved. The device should be discarded in bio-hazardous waste as per standard procedure.

Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
THE O R COMPANY CTS35-TV ColpotomizOR Tube System - 1

| Product conforms with requirements of European Medical Device Regulation 2017/745.
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| Caution, consult accompanying documents.
| Do not re-sterilize.
| Keep away from sunlight.
| Keep dry.
| Single Sterile Barrier System.
| Caution: US Federal Law restricts this device to sale by or on the order of a physician.
| Do not use if package is damaged.
| Consult Instructions for Use.
| Method of sterilization using ethylene oxide.
| Not made with natural rubber latex.
| Do not reuse.
| Medical Device.
| Single sterile barrier with protective packaging outside.
| Use-by date.

Distributed exclusively in USA by: Symmetry Surgical, 3034 Owen Drive, Antioch, TN 37013, USA
Email:customerservice@symmetrysurgical.com,
Telephone: USA & CANADA +1 800-251-3000 (Monday-Friday, 7:00AM – 5:30PM CST)
The 0 R Company Pty Ltd, 4/47 Wangara Road, Cheltenham, VIC, 3192, AUSTRALIA.www.theorcompany.com
OBELIS SA, Bd General Wahis 53, 1030 Brussels, BELGIUM, Tel: +(32) 2 7325954
Issued date: 27-04-2022

Documents / Resources

| THE O R COMPANY CTS35-TV ColpotomizOR Tube System [pdf] Instruction Manual
CTS35-TV, CTS45-TV, CTS35-TV ColpotomizOR Tube System, CTS35-TV, ColpotomizOR Tube System, Tube System
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